9/21/2014 1 Nicolas De Padova, Pharm.D Oncology Pharmacy Resident St. Luke’s Mountain States Tumor Institute Recognize the various steps in the health- system process with preparation and administration of oncology drug products Describe the standard precautions approach to handling hazardous drugs safely Identify areas for improvement in the safe handling and preparation of oncology drug products and prevention of medication errors at your own institution
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Medication Safety in Oncology Pharmacy (1)...Hazardous Drugs. NIOSH, 2008 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012 Mahar, K. Proper Handling
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9/21/2014
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Nicolas De Padova, Pharm.DOncology Pharmacy Resident
St. Luke’s Mountain States Tumor Institute
� Recognize the various steps in the health-system process with preparation and administration of oncology drug products
� Describe the standard precautions approach to handling hazardous drugs safely
� Identify areas for improvement in the safe handling and preparation of oncology drug products and prevention of medication errors at your own institution
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� Definition of Hazardous Drug
� Stages of Hazardous Drug Movement◦ Pharmacy receiving personnel ◦ Pharmacists and technicians◦ Nurses and physicians◦ Patient and family members
� Personal Safety◦ Storage◦ Preparation◦ Handling
� Medication Errors in Pharmacy
� Conclusion/Questions
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� Genotoxicity
� Carcinogenicity
� Teratogenicity or fertility impairment
� Evidence of serious organ toxicity at low doses
� First defined in 1990
� Refined ASHP definition in 2004
� Studies in animals or humans demonstrate:◦ Carcinogenicity – causes cancer
◦ Teratogenicity – damages developing fetus
◦ Reproductive toxicity – impairs fertility
◦ Organ toxicity at low doses
◦ Genotoxicity – damages DNA
◦ Structure & toxicity profiles of new drugs that mimic those of existing drugs that are considered hazardous
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� Dermal◦ Most common source◦ Direct Contact◦ Contaminated Surfaces
� Ingestion◦ Food, gum◦ Hand-to-mouth
� Inhalation◦ Vapors◦ Aerosols
� Injection◦ Sharps◦ Breakage
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� Clear cytotoxic labeling on exterior
� One cycle per package
� Unit-of-use when possible
� Unit dose packaging when appropriate
� Delivered separate from non-cytotoxic drugs
� Gloves (2 pairs)
� Eye protection when opening containers◦ Assess for damage or leaks
◦ Appropriate precautions
� Protective Clothing◦ nonabsorbent
◦ polyethylene-coated polypropylene
� Spill kits
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� Separated from non-hazardous drugs
� Visible warning labels
� Shelf barriers, bins, shelves
� Avoid storing “look-alike-sound-alike” drugs together
� Types of compounding hoods
� Prime IV tubing and remove air from syringes within a BSC
� Wipe syringes, IV bottles, and pumps with sterile gauze to remove any drug contamination
� Compounded product stored in sealed plastic container for transport
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� Nurses wear same PPE
� Change gowns when leaving patient care area
� Opportunity for patient education
� “Oral” does not mean safer than “IV”
� Avoid cutting/splitting oral chemo
� Double-flush toilet/close lid
� Latex gloves when handling oral agents
� Refrigerated oral chemo storage◦ Sealed plastic bag
� Gowns◦ Polyethylene coated polypropylene material
◦ Change every 3 hours (ASAP if spill)
◦ Do not wear outside compounding or administration area
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� Shoe covers◦ Do not wear outside compounding areas
� Head/Hair covers
� Face shields vs safety goggles
� Eye wash station
� Respiratory Protection◦ Large spills
� IV bag breaks (> 1000ml)
� Line disconnects and leaks
� Known airborne exposure to vapors/gases
� mechanically prohibit the transfer of environmental contaminants into the sterile system and prevents the escape of HDs or vapor concentrations outside the system
� NIOSH 1st recommends use (2004)
� U.S.P. 797 recommends use
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� Cost and billing challenges
� Does not replace proper aseptic technique!Does not replace proper aseptic technique!Does not replace proper aseptic technique!Does not replace proper aseptic technique!
� Lack of comparison studies between CTSD’s
� Trends
� Legislation◦ Washington – requires NIOSH compliance (2012)
◦ California – requires NIOSH compliance (2013)
◦ Maryland – legislation pending
◦ North Carolina – legislation pending
� Robotic automation◦ Standardized accuracy and automation
◦ Reduced occupational exposure
◦ Require loading and cleaning
� Remote pharmacist verification
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� 15% of all medication error fatalities reported to FDA from 1993-1998
� Estimated that 500 deaths annually due to oncology medication errors
� Narrow therapeutic ranges
� Varying dosages depending on indication
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� Distractions & Excessive interruptions
� Large distance between compounding area and pharmacy/pharmacist
� Poor packaging/labeling
� Similar sounding drug names
� Unfamiliar abbreviations
� Lack of procedure/warning stickers◦ IV vs IT administration
� Organized storage◦ Drug names (LASA’s)
� cisplatin vs carboplatin
� taxotere vs taxol
� vincristine vs vinblastine
◦ Strengths
� Reconstitution Errors◦ Vincristine IV and other formulations
◦ Vincristine never stored with intrathecal meds
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� Tall-man Lettering◦ CARBOplatin
◦ CISplatin
◦ vinBLASTine
◦ vinCRISTine
◦ DOCEtaxel
◦ PACLItaxel
� Different routes of administration for drug◦ Bortezomib (Velcade®)
� IV and SQ administration
◦ Methotrexate
� IV, IM, IT
◦ Cytarabine
� IV, IT
� Barcoding
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� All chemotherapy/biotherapy prepared for one patientone patientone patientone patient at a time
� Each chemotherapy product prepared individuallyindividuallyindividuallyindividually
� No chemo prepared without printed label
� When preparing batches, only one drug and one concentration prepared at a time
� Pharmacist verification prior prior prior prior to addition to base solution (do not use syringe pullback method)
� System used to deliver chemo to patient care areas is controlled by pharmacy
� Transported in sealed, leak-proof bag labeled as “chemotherapy” or “hazardous material”
� Chemotherapy/biotherapy ALWAYS hand delivered (never tubed)◦ Directly to chemo nurse
◦ Directly to designated/segregated storage area
� Defined timeframes for ordering/preparing established AND followed
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� Continuous Quality Improvement ◦ Actual medication errors or near-misses
◦ Other published errors from other facilities
◦ System assessment vs personal blame
� Properly trained in specific CSTD used at your institution
� Report situations that could lead to an error◦ if it looks confusing to you, it may be to others also
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� Orientation and routine training (annual)
� Primary educator (med safety specialist)
� Accidental Exposure to self/others
� Clinical staff in contact with oral chemo or waste from patients who received hazardous drug◦ Clerks
◦ Hygiene workers
◦ Sanitation workers
� Routine monitoring for HD handlers◦ Every 2-3 years
◦ Health History/assessment
� CBC
� Hepatic function panel
� Urinalysis
� Recommended by:◦ Occupational Safety & Health Administration (OSHA)
◦ NIOSH
◦ American College of Occupational and Environmental Medicine
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� National Institute for Occupational Safety and Health (NIOSH)◦ List of Antineoplastic & Other Hazardous Drugs in
Healthcare Settings 2012
� Defines categories for hazard types
� Currently updating for 2014
� American Society of Health-System Pharmacists (ASHP)◦ Guidelines on Handling Hazardous Drugs 2006
� U.S.P. 797/800
� Cohen, M.R. Medication Errors 2nd Edition. APhA, 2007� Preventing Occupational Exposures to Antineoplastic and Other
Hazardous Drugs in Health Care Settings. NIOSH, 2004� Personal Protective Equipment for Health Care Workers Who Work with
Hazardous Drugs. NIOSH, 2008� NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare
Settings 2012� Mahar, K. Proper Handling of Hazardous Drugs: Topics for Oncology
Nursing. CPE program, 2010� ISMP Medication Safety Self Assessment for Oncology (2012)� Power L.A., Polovich M., Safe Handling of Hazardous Drugs: Reviewing
Standards for Worker Protection. Pharmacy Practice News. March 2011� Furlow, B. How to Improve the safety of chemotherapy administration.
Oncology Nurse Advisor; June 2010:21-25� Goodin, S. et al. Safe Handling of Oral Chemotherapeutic Agents in
Clinical Practice: Recommendations From an International Pharmacy Panel. Journal of Oncology Practice. Jan 2011(7):7-12